Sunovion, Sumitomo Dainippon Pharma and Otsuka Enter Global Development and Commercialization Collaboration

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MARLBOROUGH, Mass. & OSAKA, Japan & TOKYO, Japan – (COMMERCIAL THREAD) – Sunovion Pharmaceuticals Inc. (Sunovion), its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the signing of a global license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of Amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.

Leveraging their complementary therapeutic expertise and capabilities, the companies plan to fully explore the medical potential of the collaborative compounds and accelerate development times, in order to deliver important treatments for people living with it. neuropsychiatric health problems around the world. Otsuka’s subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., will jointly lead, with Sunovion, efforts to advance the global research and development agenda, as well as to plan future business activities.

“Sunovion, along with our parent company Sumitomo Dainippon Pharma, is proud to partner with Otsuka on a common mission to help improve lives and health globally,” said Antony Loebel, MD, president and CEO of Sunovion. “Otsuka’s recognition of the significant value of these assets reflects Sunovion’s innovative discovery and development efforts over the past decade, as well as our expertise and commercialization capabilities in neuropsychiatry. We look forward to working with our colleagues in Otsuka as we develop new compounds to treat patients with severe neuropsychiatric disorders. ”

“We are delighted to have signed this agreement with Otsuka, which has broad global reach and significant expertise in neuropsychiatry. We will work together to develop and market pharmaceuticals of value to patients around the world faster and more reliably in the hope that these new drugs will develop, ”said Hiroshi Nomura, President and CEO of Sumitomo Dainippon Pharma. “Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of future changes in the business environment. This collaboration is a major step forward in this initiative.

“Otsuka is committed to delivering novel antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capacity and external collaborations, starting with the launch of antipsychotics in the United States in 2002,” said Makoto Inoue, president and representative director of Otsuka. “We are advancing in new areas such as the development of drugs to treat the agitation associated with Alzheimer’s-type dementia and the deployment of the world’s first digital drug. Through this agreement, we are confident that companies will be able to ” deliver even more value to patients through the experience and networks we have cultivated over many years around the world.

This collaboration recognizes that there is a great need for new treatments in the field of neuropsychiatric medicine development. The companies are focused on collaborating on solutions to address these areas of unmet medical need by offering four promising compounds (SEP-363856), SEP-4199, SEP-378614 and SEP-380135, which treat severe neuropsychiatric disorders. The goal of co-development programs is to help change the course of serious medical conditions and provide new treatment options to patients and healthcare providers around the world.

Upon completion of the deal, in addition to an upfront payment of US $ 270 million, Sunovion is eligible for development milestone payments of up to US $ 620 million for all four compounds and milestone payments. corresponding sales. Sunovion and Otsuka will share the benefits of the four compounds, as well as all expenses for clinical studies, approval applications and marketing in each country. Additional details regarding the terms of the agreement are not being disclosed.

About Sunovion compounds

The four active clinical stage ―ulotaront (SEP-363856), the non-racemic ratio of the enantiomers of Amisulpride (SEP-4199), SEP-378614 and SEP-380135― included in the collaboration cover early to late stage development. The compounds represent a scientifically unique approach to treating symptoms which are not adequately treated by current treatment options and / or for which existing treatments have an unsatisfactory safety and tolerability profile.

Ulotaront (SEP-363856), phase 3, is an amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity which is being investigated for the treatment of schizophrenia with additional indications under investigation. Ulotaront has been granted Breakthrough Therapy designation from the United States Food and Drug Administration (FDA) for the treatment of schizophrenia. Ulotaront is the first TAAR1 agonist to enter phase 3 clinical studies in adults and adolescents (13 to 17 years old) with schizophrenia.

Non-racemic Amisulpride (SEP-4199) is in phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Sunovion discovered that the pharmacology of Amisulpride is enantiomer-specific and that increasing the R-Amisulpride / S-Amisulpride ratio increases the potency of 5-HT serotonin.7 receptors versus receptors for dopamine D2. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase serotonin 5-HT levels7 activity to improve the efficacy of antidepressants and to produce reduced levels of D2 receptor occupancy suitable for the treatment of bipolar depression. In September 2021, Sunovion initiated a global Phase 3 clinical study, which is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study for the treatment of bipolar I depression in the United States. Japan will join this global clinical phase. 3 study.

SEP-378614 and SEP-380135 are in Phase 1 of development and can be viewed on the Sunovion pipeline here.

Sunovion discovered ulotaront, SEP-378614 and SEP-380135 in collaboration with PsychoGenics based in part on a mechanism independent approach using the SmartCube® in vivo phenotypic platform and associated artificial intelligence algorithms.

Sunovion has a strong portfolio of clinical and preclinical compounds, not included in this deal, which the company continues to advance for some of the most prevalent, challenging and underserved neuropsychiatric conditions.

About neuropsychiatric disorders

Neuropsychiatric disorders are among the most complex and difficult to treat. Brain disorders are often associated with significant and disabling effects on patients, affecting loved ones and society in general. Almost one in six people worldwide live with a neurological disorder,1 29 million people worldwide live with bipolar disorder,2 and 20 million people worldwide live with schizophrenia.3

About Sunovion

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious illnesses. Sunovion’s vision is to lead the way to a healthier world. The company’s innovative spirit is driven by the belief that scientific excellence combined with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has forged new paths to life-transforming treatments that reflect continued investments in research and development and an unwavering commitment to supporting people with psychiatric disorders, neurological and respiratory.

Based in Marlborough, MA, Sunovion is an indirect wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a direct wholly owned subsidiary of Sunovion Pharmaceuticals Inc. Information is available on the company’s websites: www.sunovion.com and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma

Sumitomo Dainippon Pharma is among the top 10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets including Japan, United States, China and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the fields of Psychiatry and Neurology, Oncology and Regenerative Medicine / Cell Therapy, which have been designated as priority therapeutic areas. Sumitomo Dainippon Pharma is the result of the merger in 2005 between Dainippon Pharmaceutical Co., Ltd. and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available on its website at https://www.ds-pharma.com.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the following business philosophy: “Otsuka – people creating new products for better health around the world”. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceuticals to meet unmet medical needs and nutraceuticals for the maintenance of daily health. In the pharmaceutical field, Otsuka is a leader in the challenging areas of mental, kidney and cardiovascular health and has additional research programs in oncology and several undertreated diseases, including tuberculosis, a significant global public health problem. These commitments illustrate how Otsuka is a “big business” company at heart, applying a spirit of young creativity to everything it does.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a US subsidiary of Sumitomo Dainippon Pharma Co., Ltd.

© 2021 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this press release, visit Sunovion’s website at www.sunovion.com and Otsuka’s website at www.otsuka-us.com



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